Clinical Trial Support

Title: Clinical Trial Support
Location: Bothell, WA
Duration: 12 Months (Extendable)
 
Description:
Support critical clinical research activities across multiple businesses and device platforms enabling innovation across sectors. 
 
 You are responsible for 
Entry of data into Clinical Trial Management Software (CTMS) 
 Generation of reports in CTMS 
 Assist Clinical Research Associates with the following clinical study related activities including but not limited to: 
 Support Institutional Review Board submissions / document prep and correspondence (initial, amendments, renewals) 
 Support site / study training 
 Assist in preparation of site training / study initiation materials 
 Create and maintain study binders 
 Contact and coordinate study participant recruitment and enrollment for internal trials, including: 
 Retain documentation necessary for this process 
 Initiate, coordinate, and manage activities associated with external patient trials and focus group meetings, including locating participants, securing meeting locations, developing trial procedures, and designing survey materials 
 Conduct quality audits through monitoring internally and externally (remotely or onsite) to ensure compliance with US or international regulations 
 Maintain traceability and accountability of study devices 
 Follow procedures to order study equipment 
 Assist with device labeling, modified product process, set-up and shipments 
 Manage return and disposition of study equipment 
 Manage (generate and track) Purchase Orders (PO’s) to facilitate study payments to sites and vendors 
 Data Entry and Validation 
 User Assessment Testing (UAT) of Electronic Data Capture (EDC) system 
 develop Excel spreadsheets for data capture 
 validate / audit per validation plan 
 Initiate and track requests for legal agreements 
 Support the timely and accurate compilation of: all study data, study reports, including SAP file / document entries 
 Maintain professional relationships with internal associates 
 
 You are a part of 
This position supports global clinical and scientific affairs for Philips which is integral to the assurance of Good Clinical Practice compliance and support of business needs and new product development. Our organization works closely with regulatory, quality, marketing and research and development, among other departments. 
 
 To succeed in this role, you should have the following skills and experience 
BA or BS in biological sciences or related field, or RN or if an Intern a student in one of these areas 
 work experience in life science or medically related field 
 prior experience providing administrative support in a clinical trial or data management setting 
 awareness and working knowledge of applicable clinical research regulatory requirements i.e., good clinical practice (GCP) and International Conference on Harmonisation (ICH) guidelines preferred 
 knowledge and experience in budgeting, accounting and contracting is preferred 
 self-motivated individual able to manage multiple tasks and priorities in an efficient manner 
 Can work independently without direct supervision as well as in a team environment 
 ability to work according to standard operating procedures 
 computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint 
 strong written and verbal communication skills in English 
 effective time management, planning and organizational skills 
 attention to detail and accuracy in work 
 strong problem-solving skills and proactive attitude


Looking forward,
 
Sachin Patil
APN Software Services, Inc
Phone: 510-402-1063
sachin@apninc.com  

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